JVT Journal Articles
Vol. 15, Issue 4, Nov 2009

Ed White
The following key points are discussed in this article: Construction and qualification of a new aseptic processing area is a complex project involving multiple disciplines Good upfront strategic planning is critical for an effective qualification effort.
Scott Sutton, Ph.D.
The following key points are addressed in this article: Good personal hygiene is a requirement of all pharmaceutical activities, from operating on the line through validations. However, studies show poor compliance as a rule to basic hand washing technique. Poor hand washing technique may result in increased absenteeism, particularly in time...
The following key points are discussed in this article: This discussion addresses the use of enabling technology in computer system validation (CSV) projects to most efficiently achieve the validated state in a pragmatic cost-effective manner Requirements definition management (RDM) and automated testing software are used regularly for the...
John E. Lincoln
The following key points are discussed in this article: ISO 14971:2007 requires the manufacturer of medical devices to make judgments relating to safety of the medical device, including the acceptability of risks, and provides a format and suggested tools to use in the identification of the hazards The risk management process includes the...
The following key points are discussed in this article: Ultrafiltration (UF) is a commonly used biotech process for concentrating a dilute product stream.
Bernard McGarvey
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Brian K. Nunnally
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John McConnell
The following is a list of key points discussed in this article: The use of controls and blind controls is good science and is an expectation of any world class laboratory Control samples should be representative material, stable for a long period of time, be homogeneous, and have sufficient supply Proper control charts can illuminate best...
The following key points are addressed in this article: Bioavailability refers to the rate and extent of a therapeutically active drug that reaches the systemic circulation, thereby accessing the site of action Bioavailability of an oral dosage form may be understood from three perspectives: Anatomical and physiological features of the...
Pramote Cholayudth
Process capability index (CpK) is probably the most recognized traditional process performance index used in pharmaceutical technology. It is widely employed in quality by design (QbD), process validation, and annual product review activities (1, Figure 1). In process validation, the CpK (Figure 2) for a certain critical quality attribute (CQA) is...
Rizwan Sharnez, Ph.D.
This article addresses issues related to cleaning that impact clean-in-place (CIP) cycle development, new product introductions (NPIs), and validation of multiproduct equipment. These operations present some unique and complex challenges. A relatively simple strategy for overcoming these challenges is presented. The strategy is based on using...
Material of construction is a factor in recovery of residue for cleaning validation. Analysis of existing recovery data demonstrated that recovery factors for drug products on different materials of construction could be categorized into several groupings. The groupings based on the recovery data were not aligned with the material composition (e...
The following key points are discussed in this article: Pharmaceutical compounds with specific physical properties may be patentable It is important to show a correlation between the specific physical property and a useful benefit in manufacturing, stability, or some other area Although polymorphism is a common phenomenon, the existence of...

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